二尖瓣关闭不全的介入治疗新进展

为了减轻二尖瓣关闭不全外科手术和体外循环所带来的创伤和风险,基于外科边对边缝合和瓣环成形的手术方式,近年来二尖瓣关闭不全的介入治疗得到了快速发展,包括经二尖瓣边对边修补术和瓣环成形术,前者经穿房间隔途径送入钳夹装置或负压抽吸缝合装置,钳夹或缝合前后瓣边缘,形成双孔二尖瓣,后者经右颈内静脉途径把缩环装置植入冠状静脉窦内,缩短瓣环前后径,以减轻二尖瓣反流。两种方法均已从动物实验过渡到临床试验,均显示了良好的治疗作用,但还需技术上的进一步改进和长期大规模的临床评价。     

Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation

BackgroundMitral valve transcatheter edge-to-edge repair is safe and effective in treating degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk, but outcomes in complex mitral valve anatomy patients vary.ObjectivesThe PASCAL IID registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive risk patients with significant symptomatic DMR and complex mitral valve anatomy.MethodsPatients in the prospective, multicenter, single-arm registry had 3+ or 4+ DMR, were at prohibitive surgical risk, presented with complex anatomic features based on the MitraClip instructions for use, and were deemed suitable for the PASCAL system by a central screening committee. Enrolled patients were treated with the PASCAL system. Safety, effectiveness, and functional and quality-of-life outcomes were assessed. Study oversight also included an echocardiographic core laboratory and clinical events committee.ResultsThe study enrolled 98 patients (37.2% ≥2 independent significant jets, 15.0% severe bileaflet/multi scallop prolapse, 13.3% mitral valve orifice area <4.0 cm², and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P < 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001).ConclusionsThe outcomes of the PASCAL IID registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy. (PASCAL IID Registry within the Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID] NCT03706833)     

Impact of the Leaflet-to-Annulus Index on Residual Mitral Regurgitation in Patients Undergoing Edge-to-Edge Mitral Repair

ObjectivesThis study sought to investigate the clinical impact of leaflet-to-annulus mismatch on residual mitral regurgitation (MR) after percutaneous edge-to-edge mitral repair.BackgroundAnnular dilation is a common feature of secondary MR, which requires concomitant annuloplasty in surgical mitral valve repair.MethodsConsecutive MR patients undergoing MitraClip (Abbott Vascular, Santa Clara, California) implantation in the Heart Center Bonn were enrolled. Residual MR was defined as a post-procedural MR ≥2+ and patients were stratified into 2 groups according to the residual MR. The study calculated the leaflet-to-annulus index (LAI) using pre-procedural 2- and 3-dimensional transesophageal echocardiography. All-cause death within a 1-year follow-up was examined.ResultsOf 420 consecutive patients, 117 (27.9%) patients had residual MR (≥2+). Patients with residual MR had a significantly lower pre-procedural LAI than did those with MR <2+ (median 1.14 [interquartile range (IQR): 1.07 to 1.20] vs. 1.18 [IQR: 1.12 to 1.29]; p < 0.001). A multivariable analysis revealed that the LAI value was significantly associated with residual MR (odds ratio: 0.95; p < 0.001). After 1-year follow-up, patients with residual MR had a significantly worse prognosis than did patients with MR <2+ (estimated mortality rate 17.4% vs. 7.3%; log-rank p = 0.002), and the presence of residual MR was independently correlated with 1-year mortality (hazard ratio: 2.74; p = 0.004).ConclusionsThe LAI value is associated with residual MR after MitraClip implantation, which is independently correlated with 1-year mortality. This index might be a useful tool to identify patients with the need for concomitant annuloplasty before edge-to-edge repair.     

Improved Functional Status and Quality of Life in Prohibitive Surgical Risk Patients With Degenerative Mitral Regurgitation After Transcatheter Mitral Valve Repair

Background

Surgical mitral valve repair (SMVR) remains the gold standard for severe degenerative mitral regurgitation (DMR). However, the results with transcatheter mitral valve repair (TMVR) in prohibitive-risk DMR patients have not been previously reported.

Objectives

This study aimed to evaluate treatment of mitral regurgitation (MR) in patients with severe DMR at prohibitive surgical risk undergoing TMVR.

Methods

A prohibitive-risk DMR cohort was identified by a multidisciplinary heart team that retrospectively evaluated high-risk DMR patients enrolled in the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II studies.

Results

A total of 141 high-risk DMR patients were consecutively enrolled; 127 of these patients were retrospectively identified as meeting the definition of prohibitive risk and had 1-year follow-up (median: 1.47 years) available. Patients were elderly (mean age: 82.4 years), severely symptomatic (87% New York Heart Association class III/IV), and at prohibitive surgical risk (STS score: 13.2 ± 7.3%). TMVR (MitraClip) was successfully performed in 95.3%; hospital stay was 2.9 ± 3.1 days. Major adverse events at 30 days included death in 6.3%, myocardial infarction in 0.8%, and stroke in 2.4%. Through 1 year, there were a total of 30 deaths (23.6%), with no survival difference between patients discharged with MR ≤1+ or MR 2+. At 1 year, the majority of surviving patients (82.9%) remained MR ≤2+ at 1 year, and 86.9% were in New York Heart Association functional class I or II. Left ventricular end-diastolic volume decreased (from 125.1 ± 40.1 ml to 108.5 ± 37.9 ml; p < 0.0001 [n = 69 survivors with paired data]). SF-36 quality-of-life scores improved and hospitalizations for heart failure were reduced in patients whose MR was reduced.

Conclusions

TMVR in prohibitive surgical risk patients is associated with safety and good clinical outcomes, including decreases in rehospitalization, functional improvements, and favorable ventricular remodeling, at 1 year. (Real World Expanded Multi-center Study of the MitraClip System [REALISM]; NCT01931956)     

Usefulness of Intraprocedural Pulmonary Venous Flow for Predicting Recurrent Mitral Regurgitation and Clinical Outcomes After Percutaneous Mitral Valve Repair With the MitraClip

Objectives

The aim of this study was to determine the prognostic value of pulmonary venous (PV) flow during MitraClip implantation.

Outcomes After Transcatheter Edge-to-Edge Mitral Valve Repair According to Mitral Regurgitation Etiology and Cardiac Remodeling

BackgroundTranscatheter edge-to-edge repair (TEER) has been increasingly used for selected patients with mitral regurgitation (MR), but limited data are available regarding clinical outcomes in patients with varied etiology and mechanism of MR.ObjectivesThe aim of this study was to evaluate the outcomes of TEER according to etiology and left ventricular (LV) and left atrial remodeling.MethodsConsecutive patients who underwent TEER between 2007 and 2020 were included in the analysis. Among patients with functional MR (FMR), those with predominant LV remodeling were classified as having ventricular FMR (v-FMR), whereas those without LV remodeling but predominant left atrial remodeling were classified as having atrial FMR (a-FMR). The primary outcome was a composite of all-cause mortality and heart failure hospitalization at 2 years and was compared among patients with degenerative MR (DMR), a-FMR, and v-FMR.ResultsA total of 1,044 patients (11% with a-FMR, 48% with v-FMR, and 41% with DMR) with a mean Society of Thoracic Surgeons score of 8.6 ± 7.8 underwent TEER. Patients with a-FMR had higher rates of atrial fibrillation and severe tricuspid regurgitation with larger left and right atria, whereas patients with v-FMR had lower LV ejection fractions with larger LV dimensions. Residual MR more than moderate at discharge was not significantly different among the 3 groups (5.2% vs 3.2% vs 2.6%; P = 0.37). Compared with patients with DMR, 2-year event rates of the primary outcome were significantly higher in patients with a-FMR and v-FMR (21.6% vs 31.5% vs 42.3%; log-rank P < 0.001).ConclusionsDespite excellent procedural outcomes, patients with a-FMR and v-FMR had worse clinical outcomes compared with those with DMR.